Biogen – Talk Bio

FDA Approves Roche’s Biogen-Partnered Gazyva for Lupus Nephritis

6 days ago talkbio0Tagged Biogen, Gazyva, Lupus Nephritis, obinutuzumab, Roche (company), treatment approval, United States Food and Drug Administration

Gazyva; obinutuzumab; Roche; Biogen; FDA; lupus nephritis; treatment approval

Biogen Shuffles Staff and Exits AAV Gene Therapy Programs After Strategic Shift

4 weeks ago talkbio0Tagged AAVS1 gene, Biogen, Biotech Layoffs, Discontinuation (procedure), gene therapy, layoffs, Pharma, staff reorganization

Biogen; AAV gene therapy; layoffs; staff reorganization; biotech layoffs; pharma restructuring; gene therapy discontinuation

Biogen Plans Resubmission After FDA Declines High-Dose Spinraza for SMA, Requests More Production Information

1 month ago talkbio0Tagged Biogen, Candidiasis, Chronic Mucocutaneous, Complete, controls, High dose, Manufacturing, New Drug Application, nusinersen, regulatory, Response Letter, resubmission, Science of Chemistry, Spinal Muscular Atrophy, Spinraza, United States Food and Drug Administration

Biogen; Spinraza; nusinersen; high dose; FDA; Complete Response Letter; spinal muscular atrophy; SMA; supplemental New Drug Application; Chemistry Manufacturing and Controls; CMC; regulatory; resubmission

Eisai Secures FDA Approval for Leqembi Autoinjector for Maintenance Dosing in Alzheimer’s Patients

2 months ago talkbio0Tagged Alzheimer 's disease, Approved, at-home, AutoInjector, Biogen, dosing, Eisai, Lecanemab, Leqembi, Maintenance, Subcutaneous Injections, United States Food and Drug Administration

Eisai; Leqembi; lecanemab; FDA approval; autoinjector; subcutaneous injection; maintenance dosing; Alzheimer’s disease; at-home treatment; Biogen

Biogen Pledges $2 Billion Manufacturing Investment in North Carolina

3 months ago talkbio0Tagged Antisense Oligonucleotides, Artificial Intelligence, Automation, Biogen, Biotechnology, expansion, gene therapy, Investments, Manufacturing, North Carolina, Research Triangle Park

Biogen; manufacturing investment; North Carolina; Research Triangle Park; biotechnology; antisense oligonucleotides; gene therapy; automation; AI; expansion

Biogen Ushers Spinraza Follow-Up (Salanersen) Into Pivotal SMA Studies

4 months ago talkbio0Tagged Antistreptolysin O, Biogen, Clinical Trials, motor milestones, Nerve Degeneration, Novartis, Pediatric brand name, Phase III, salanersen, Spinal Muscular Atrophy, Spinraza, Zolgensma

Biogen; SMA; Spinraza; salanersen; Phase III; clinical trials; neurodegeneration; motor milestones; pediatric; Novartis Zolgensma; ASO therapy

Sage Therapeutics Acquired by Supernus Pharmaceuticals in $561M Deal

4 months ago talkbio0Tagged Acquisition, Biogen, Deal Value, Depression, Postpartum, Drug Industry, Supernus Pharmaceuticals, Zurzuvae

Sage Therapeutics; Supernus Pharmaceuticals; acquisition; Zurzuvae; postpartum depression; biotech; pharmaceutical industry; major depressive disorder; Biogen; deal value